Determination of CMV-specific T-cell frequencies after allogeneic or haploidentical hematopoietic stem cell transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031287

Enrollment

Registered

2023-03-06

Start date

2022-10-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients after allogeneic or haploidentical blood stem cell transplantation

Interventions

Group 1: CMV-positive stem cell transplant recipients. Group 2: CMV-negative stem cell transplant recipients.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: CMV IgG-positive donor or recipient Condition after allogeneic or haploidentical blood stem cell transplantation Signed informed consent form

Exclusion criteria

Exclusion criteria: No capacity to consent Refusal to participate Donor or recipient CMV IgG-negative

Design outcomes

Primary

Measure	Time frame
Identification of patients at risk for CMV reactivation after allogeneic or haploidentical hematopoietic stem cell transplantation despite prophylaxis with letermovir. For this purpose, a so-called ELISPOT examination from peripheral blood will be performed at different time points after transplantation (day +100, +200, as well as at the first CMV detection by PCR and 1 and 3 months after CMV reactivation and - if necessary - in the further course). This examination allows to estimate the frequency of CMV-specific T cells in the patient's blood.	—

Measure

Time frame

Identification of patients at risk for CMV reactivation after allogeneic or haploidentical hematopoietic stem cell transplantation despite prophylaxis with letermovir. For this purpose, a so-called ELISPOT examination from peripheral blood will be performed at different time points after transplantation (day +100, +200, as well as at the first CMV detection by PCR and 1 and 3 months after CMV reactivation and - if necessary - in the further course). This examination allows to estimate the frequency of CMV-specific T cells in the patient's blood.

—

Secondary

Measure	Time frame
To determine the duration to reconstitution of CMV-specific T cells after transplantation with CMV+ and CMV- donors. Determination of a threshold for sufficient T cell activity to prevent CMV reactivation.	—

Countries

Germany

Contacts

Public ContactNadine Lübke

Universitätsklinikum Düsseldorf

Nadine.Luebke@med.uni-duesseldorf.de+492118110556

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026